The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

PHASE4RecruitingINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

November 8, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
HemopatchBreast CancerAxillary Lymphadenectomy
Interventions
DEVICE

Hemopatch

"HEMOPATCH Sealing Hemostat (HEMOPATCH) consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate).~Due to its flexible structure, the application of HEMOPATCH to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant.~HEMOPATCH is supplied in the following 3 sizes:~* HEMOPATCH 27 x 27 mm~* HEMOPATCH 45 x 45 mm~* HEMOPATCH 45 x 90 mm"

OTHER

Control group

No sealant (liquid, gel or patch) + suction drain

Trial Locations (1)

45004

RECRUITING

General Surgery and Digestive System Service, Toledo

All Listed Sponsors
collaborator

Asociación De Cirujanos De Mama De Toledo

OTHER

lead

Instituto de Investigación Hospital Universitario La Paz

OTHER